Diphenhydramine HCl Oral Solution DIPHENHYDRAMINE HYDROCHLORIDE NATCO PHARMA USA LLC FDA Approved Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL) Diphenhydramine HCl USP 12.5 mg Active ingredient (in each 10 mL) Diphenhydramine HCl USP 25 mg
Inactive Ingredients
Inactive ingredients Citric acid D&C Red No. 33 FD&C Red No. 40 flavor glycerin poloxamer 407 purified water sodium benzoate sodium chloride sodium citrate and sucrose.
Strengths
5 ml 12.5 mg 10 ml 25 mg
Quantities
5 ml 10 ml
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To Hay Fever Or Other Upper Respiratory Allergies Runny Nose Sneezing Itchy Watery Eyes Itchy Throat
Pill Appearance
Color: red

Identifiers & Packaging

Container Type UNKNOWN
UPC
0369339152010 0369339151051
UNII
TC2D6JAD40
Packaging

How Supplied Each 5 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 12.5mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms: NDC 69339-151-05 (1) unit dose cup 5mL NDC 69339-151-17 40 (4x10) unit dose cups 5mL NDC 69339-151-19 100 (10x10) unit dose cups 5mL Each 10 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 25mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms: NDC 69339-152-01 (1) unit dose cup 10mL NDC 69339-152-17 40 (4x10) unit dose cups 10mL NDC 69339-152-19 100 (10x10) unit dose cups 10mL; PRINCIPAL DISPLAY PANEL Delivers 5 mL NDC 69339-151-05 Diphenydramine HCl Oral Solution, USP 12.5 mg/5 mL For Institutional Use Only 3 69339 15105 1 Lot # 000000 Exp: MM/YYY See Insert DASH Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE Principal Display Panel; PRINCIPAL DISPLAY PANEL Delivers 10 mL NDC 69339-152-01 Diphenydramine HCl Oral Solution, USP 25 mg/10 mL For Institutional Use Only 3 69339 15201 0 Lot # 000000 Exp: MM/YYY See Insert DASH Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE Principal Display Panel

Package Descriptions
  • How Supplied Each 5 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 12.5mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms: NDC 69339-151-05 (1) unit dose cup 5mL NDC 69339-151-17 40 (4x10) unit dose cups 5mL NDC 69339-151-19 100 (10x10) unit dose cups 5mL Each 10 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 25mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms: NDC 69339-152-01 (1) unit dose cup 10mL NDC 69339-152-17 40 (4x10) unit dose cups 10mL NDC 69339-152-19 100 (10x10) unit dose cups 10mL
  • PRINCIPAL DISPLAY PANEL Delivers 5 mL NDC 69339-151-05 Diphenydramine HCl Oral Solution, USP 12.5 mg/5 mL For Institutional Use Only 3 69339 15105 1 Lot # 000000 Exp: MM/YYY See Insert DASH Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE Principal Display Panel
  • PRINCIPAL DISPLAY PANEL Delivers 10 mL NDC 69339-152-01 Diphenydramine HCl Oral Solution, USP 25 mg/10 mL For Institutional Use Only 3 69339 15201 0 Lot # 000000 Exp: MM/YYY See Insert DASH Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE Principal Display Panel

Overview

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat

Indications & Usage

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat

Dosage & Administration

Directions • Use the following dosage guidelines when using this product Age (yr) Dose (mL) Adults and children 12 years and older take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours. Children 6 years to under 12 years take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours Children under 6 years ask a doctor

Warnings & Precautions
Warnings Do not use • in neonates or premature infants • if pregnant or breast-feeding • if hypersensitive to diphenhydramine HCI and other similar antihistamine • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy Ask a doctor before use if you have • glaucoma • a breathing problem such as emphysema or chronic bronchitis • a sodium restricted diet • trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives When using this product • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Purpose

Purpose Antihistamine

Do Not Use

Do not use • in neonates or premature infants • if pregnant or breast-feeding • if hypersensitive to diphenhydramine HCI and other similar antihistamine • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy

When Using

When using this product • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Questions

Questions or comments? Call 201-786-6500 Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458 DP-UD-PI-AT-[117894] Rev 08/20


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